Legal requirements

The EU member states apply the same product specific regulation. Products need to live up to these rules, whether the product is produced in the EU or imported into the EU. Please note that there are some areas where additional national legal requirements may exist.

The legal requirements are largely harmonised, which means that they apply in all EU member states. So, if your products meet the EU requirements they are valid in all EU countries. There are requirements that applies to most products sold in the EU, whereas food products need to live up to the so called sanitary and phytosanitary requirements.

Technical requirements

Technical requirements are rules that define the characteristics of a product such as dimension, labelling, packaging, level of quality, conformity assessment procedures, etcetera. These requirements could also be about production methods and processes. Technical requirements are in place to protect the public from health and safety risks related to the manufacturing or use of products.

Technical requirements apply to almost all products. This could be general safety requirements or a specific requirement for a specific product, for example labelling requirements for textiles. Sometimes a product has to be CE marked. By affixing the CE marking to a product, a manufacturer declares that the product meets all the legal requirements for CE marking, for example on safety and functionality for a specific product. CE marking on the EU commission website

Requirements for agricultural products

Agricultural products normally need a health certificate and/or will be checked before they are allowed to enter the EU. Regulations for agricultural products are in place to protect humans, animals, and plants from diseases, pests, or contaminants (sanitary and phytosanitary (SPS) measures).

Imports of food into the EU must comply with requirements concerning, for example, traceability, hygiene and maximum levels of certain contaminants or pesticides in food. This area is covered by EU legislation and therefore mandatory for all members states. The legislation is designed to prevent risks to public health and protect consumer interests.

Certain products need certificate from laboratory

To show that your food products do not contain residue levels of contaminants or pesticides that exceed the maximum levels, you need to have your product tested in a laboratory. All fresh fruits and vegetables need to be accompanied by a phytosanitary certificate to be allowed onto the EU market. However, certain plants are exempted from this obligation such as pineapples, coconuts, durians, bananas, and dates. List of products that need and do not need certificates (EUR-Lex website)

Food of animal origin

Imports of food of animal origin into the EU must comply with additional requirements. Products of animal origin can only be imported to Sweden from countries that have been approved and listed by the EU. The country of export must have control procedures in place to check the capacity of establishments to produce in a way that lives up to EU standards.

The products must come from an establishment registered by the responsible authority in the exporting country and that is approved by the EU. The establishments and their products must fulfil requirements on traceability, hygiene and maximum levels of certain contaminants, pesticides, and veterinary medicines in food. Products of animal origin exported to the EU must be accompanied by a common health entry document issued by the relevant national authority in the exporting country. The requirements on food of animal origin are in place to prevent risks to public health, and to protect consumer interests. List of registered establishments outside the EU (EU commission website)

Non-harmonised legal requirements

Not all legal requirements have been harmonised in the EU. For certain products, member states are free to set out national requirements. For example, the regulatory framework for material in contact with foods, such as plastic bottles, is not fully harmonised. A plastic bottle that meets the requirements of one member state in terms of chemical substances, bisphenol-A for example, may not meet the requirements of another member state. This is often the case where member states have not yet agreed on common levels.

How to find the legal requirements

In order to export your products to the EU market, you need to know what requirements apply and how to meet them. You can find the requirements applicable to your product at the Access2Markets, a free online tool from the European Commission. Search the requirements by using your product code. Access2Markets

Get further support

Feel free to contact us at Open Trade Gate Sweden. We can assist you with finding the legal requirements for your product. We will also let you know if there are non-harmonised legal requirements for your product in Sweden.

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Open Trade Gate Sweden

Phone: +46 8 690 48 00

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